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ADMELOG SOLOSTAR is a brand name for Insulin Lispro, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: The indications have been granted on the basis of similarity between ADMELOG and the reference biologic drug, HUMALOG. ADMELOG (insulin lispro injection), is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. ADMELOG insulin is also…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 05/2021 7 WARNINGS AND PRECAUTIONS 05/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 6 5. 7 6. 7 7. 1 Special Populations ............................................................................................
12 8. ADVERSE REACTIONS .................................................................................................. 1 Adverse Reaction Overview................................................................................ 2 Clinical Trial Adverse Reactions ..........................................................................
5 Post-Market Adverse Reactions.......................................................................... 13 9. DRUG INTERACTIONS.................................................................................................. 4 Drug-Drug Interactions ......................................................................................
5 Drug-Food Interactions ...................................................................................... 6 Drug-Herb Interactions ...................................................................................... 7 Drug-Laboratory Test Interactions ......................................................................
14 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action.................................................................................... 2 Pharmacodynamics ......................................................................................
3 Pharmacokinetics......................................................................................... 15 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 17 12 SPECIAL HANDLING INSTRUCTIONS.............................................................................
18 PART II: SCIENTIFIC INFORMATION ........................................................................................ 19 13 PHARMACEUTICAL INFORMATION..............................................................................
19 14 CLINICAL TRIALS.......................................................................................................... 1 Trial Design and Study Demographics ........................................................... 2 Study Results ...............................................................................................
). Care should be taken to ensure that a blood vessel has not been entered. The injection site should not be massaged. Instructions for Use/Handling To prevent the possible transmission of disease, never share an ADMELOG pen or cartridge between patients, even if the needle on the delivery device is changed.
Mixing of Insulins:
Mixing insulin lispro 100 units/mL with insulin NPH does not decrease the absorption rate or the total bioavailability of insulin lispro. Given alone or mixed with insulin NPH, insulin lispro results in a more rapid absorption and glucose-lowering effect compared with human regular insulin.
If ADMELOG 100 units/mL is mixed with a longer-acting insulin such as insulin NPH, ADMELOG should be drawn into the syringe first to prevent clouding of the ADMELOG by the longer-acting insulin. Injection should be made immediately after mixing.
Mixtures should not be administered intravenously. ADMELOG should not be diluted or mixed with any other insulin when used in a subcutaneous insulin infusion pump. 5 unit dose increments • AllStar PRO which delivers ADMELOG in 1 unit dose increments.
These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens. Product Monograph ADMELOG® and ADMELOG® SoloSTAR® Page 7 of 66 5. OVERDOSAGE With the rapid onset of activity of ADMELOG, it is important that the insulin analogue be given close to mealtime (within 15 minutes before a meal).
When necessary, ADMELOG may be given shortly after a meal instead (within 20 minutes of the start of the meal). A significant deviation could put the patient at risk of hypoglycemia. Insulins have no specific overdose definitions because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes.
05/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 6 5. 7 6. 7 7. 1 Special Populations ............................................................................................
12 8. ADVERSE REACTIONS .................................................................................................. 1 Adverse Reaction Overview................................................................................ 2 Clinical Trial Adverse Reactions ..........................................................................
5 Post-Market Adverse Reactions.......................................................................... 13 9. DRUG INTERACTIONS.................................................................................................. 4 Drug-Drug Interactions ......................................................................................
5 Drug-Food Interactions ...................................................................................... 6 Drug-Herb Interactions ...................................................................................... 7 Drug-Laboratory Test Interactions ......................................................................
14 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action.................................................................................... 2 Pharmacodynamics ......................................................................................
3 Pharmacokinetics......................................................................................... 15 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 17 12 SPECIAL HANDLING INSTRUCTIONS.............................................................................
ADMELOG (insulin lispro injection) is contraindicated during episodes of hypoglycemia (see 5 OVERDOSAGE) and in patients sensitive to insulin lispro or any of the excipients they contain (for a complete list of excipients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Insulin Lispro in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
3 Comparative Bioavailability Studies .............................................................. 4 Immunogenicity ........................................................................................... 5 Clinical Trials - Reference Biologic Drug .........................................................
26 15 MICROBIOLOGY ................................................................................................................ 29 16 NON-CLINICAL TOXICOLOGY..............................................................................................
1 Comparative Non-Clinical Pharmacology and Toxicology ............................... 34 17 SUPPORTING PRODUCT MONOGRAPHS...................................................................... 34 PATIENT MEDICATION INFORMATION – ADMELOG® Vial .......................................................
35 PATIENT MEDICATION INFORMATION - ADMELOG® Cartridge ............................................... 43 PATIENT MEDICATION INFORMATION - ADMELOG® SoloSTAR® ............................................. 51 ADMELOG® SoloSTAR® - INSTRUCTIONS FOR USE […]
Hypoglycemia may occur as a result of an excess of insulin or ADMELOG relative to food intake and energy expenditure or in patients who have an infection or become ill (especially with diarrhea or vomiting). Hypoglycemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.
Mild hypoglycemic episodes will respond to oral administration of glucose or sugar-containing foods. Correction of moderately severe hypoglycemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently.
Patients who fail to respond to glucagon must be given glucose solution intravenously. Patients who are unable to take sugar orally or who are unconscious should be treated with intravenous administration of glucose at a medical facility or should be given an injection of glucagon (either intramuscular or subcutaneous).
The patient should be given oral carbohydrates as soon as consciousness is recovered. For management of a suspected drug overdose, contact your regional poison control centre. 6. 5 mg insulin lispro, corresponding to 100 units of insulin lispro.
7. 15 mg/ml], water (for injection), zinc oxide Product Monograph ADMELOG® and ADMELOG® SoloSTAR® Page 8 of 66 General As with all insulin therapies, the duration of action of ADMELOG may vary in different individuals or in the same individual according to dose, injection site, blood flow, temperature and level of physical activity.
Hypokalemia is among the potential clinical adverse effect associated with the use of all insulin therapies, including ADMELOG. g. diarrhea). Stress or concomitant illness, especially infectious and febrile conditions may change insulin requirements.
In these instances, patients should contact their physician and carefully control their blood glucose. To avoid transmission of disease, a cartridge or prefilled syringe should not be used by more than one person. Insulin lispro had a similar safety profile to HUMULIN® R (insulin injection (rDNA origin) Regular) over the course of the clinical studies with insulin lispro 100 units/mL.
Insulin lispro has been shown to control glycosylated hemoglobin (HbA1c) levels as effectively as human insulin in comparator studies specifically designed to study mealtime therapy without optimization of basal insulin regimens. Once a patient is using ADMELOG, reassessment and adjustment, as necessary, of the basal insulin regimen (dosage and number of injections) has been shown to optimize overall glycemic control.
Any rapid- or short-acting insulin formulation should be used with caution in patients with gastroparesis. However, some patients with gastroparesis may benefit from postprandial administration of ADMELOG, which has been shown to provide postprandial glycemic control similar to that provided by human insulin injected 30 minutes pre-prandially.
Using the postprandial dosing approach, the insulin dose can be adjusted according to the actual […]
18 PART II: SCIENTIFIC INFORMATION ........................................................................................ 19 13 PHARMACEUTICAL INFORMATION..............................................................................
19 14 CLINICAL TRIALS.......................................................................................................... 1 Trial Design and Study Demographics ........................................................... 2 Study Results ...............................................................................................
3 Comparative Bioavailability Studies .............................................................. 4 Immunogenicity ........................................................................................... 5 Clinical Trials - Reference Biologic Drug .........................................................
26 15 MICROBIOLOGY ................................................................................................................ 29 16 NON-CLINICAL TOXICOLOGY..............................................................................................
1 Comparative Non-Clinical Pharmacology and Toxicology ............................... 34 17 SUPPORTING PRODUCT MONOGRAPHS...................................................................... 34 PATIENT MEDICATION INFORMATION – ADMELOG® Vial .......................................................
35 PATIENT MEDICATION INFORMATION - ADMELOG® Cartridge ............................................... 43 PATIENT MEDICATION INFORMATION - ADMELOG® SoloSTAR® ............................................. 51 ADMELOG® SoloSTAR® - INSTRUCTIONS FOR USE […]